A Varegacestat Hepatic Impairment Study

Phase 1

Recruiting

• Conditions: Healthy Volunteer; Hepatic Impairment (HI)
• Interventions: Drug: varegacestat

• Registration Number: NCT06841315
• Lead Sponsor: Immunome, Inc.

Brief Summary

This clinical trial is designed to determine the pharmacokinetics, safety and tolerability of varegacestat in people with impaired liver function compared to people with normal liver function.

Detailed Description

This is an open-label, single-dose, parallel study to evaluate the effects of varying degrees of impaired hepatic function on the PK, safety, and tolerability of varegacestat in adult participants.

The study will be conducted sequentially. The study will enroll participants with mild (Group 2) and moderate (Group 3) hepatic impairment (HI) and healthy participants with normal hepatic function (Group 1) at a 1:1 ratio. Matched healthy participants may match to more than one participant in the HI groups. Subsequently, if appropriate, the study will enroll participants with severe (Group 4) HI and healthy participants with normal hepatic function (Group 1), as needed, to provide 1:1 matches for Group 4. The decision to conduct Group 4 enrollment will be contingent upon the assessment of the feasibility, PK, and safety data from Groups 1-3.

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-24
• Status Verified: 2025-03
• Study Start: 2025-03-07
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	varegacestat	Single oral dose of varegacestat administered on study day 1

Primary Outcome Measures

Name	Time	Method
PK of varegacestat and metabolite from a single oral dose of varegacestat in hepatic impaired adult participants to matched healthy adult participants.	Up to 4 weeks	Cmax for varegacestat and metabolite

Secondary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of a single oral dose of varegacestat in hepatic impaired adult participants and in matched healthy adult participants.	Up to 4 weeks	Number of subjects who experience 12-lead ECG abnormalities

Trial Locations

Locations (2)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

The Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States